Part 1. Overview Information

Key Dates

August 1, 2025

All applications are due by 11:59 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Not Applicable

Not Applicable

Conformance to all requirements, both in the the Research (R) Instructions How to Apply - Application Guide and in the NOFO, is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV of this NOFO or an applicable related Notice posted to the Guide for Grants and Contracts. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The purpose of this funding opportunity is to implement the Integrated Food Safety System (IFSS) Regulatory and Laboratory Training System (RLTS) National Coordination Center (NCC) and Learning Management System (LMS), which ensures the IFSS partners’ competency needs are met and sustains a well-trained, knowledgeable human and animal food (HAF) regulatory and laboratory workforce across the IFSS.

The purpose of this NOFO will be accomplished through 5 overarching goals which correspond to the 5 strategic goals in the RLTS Strategic Plan (2024-2028):

1. Training Content: Review and standardize training content evaluation and mapping to National Curriculum Standards (NCS).
2. Training Design: Develop systems and processes that encourage the design and development of flexible training that meets Human & Animal Food (HAF) regulatory and laboratory workforce needs.
3. Training Delivery: Facilitate the delivery of National Coordination Center (NCC) approved courses to maximize access and meet stakeholder needs.
4. Management and Maintenance: Manage and maintain the IFSS regulatory and laboratory training system and learning management system (LMS).
5. Collaboration and Consistency: Collaborate with stakeholders to ensure the effectiveness, consistency, and quality of training. 

TRAINING CONTENT

• Develop and maintain the IFSS Food Protection Professionals National Curriculum Standard (NCS) and Food and Feed Laboratory National Curriculum Standard, in collaboration with FDA and state, local, tribal and territorial (SLTT) subject matter experts (SMEs), relevant associations, and the Partnership for Food Protection (PFP).
• Keep NCS competencies updated to address technological advancements, regulatory changes, and emerging issues.
• Identify and prioritize the training needs of HAF regulatory and laboratory officials, working in collaboration with the FDA and SLTT partners.
• Work with FDA, SLTT, association, and other IFSS partners to improve HAF regulatory and laboratory training based on public health impact.
• Design and facilitate the development of free and low-cost accessible training courses and other learning resources covering the NCS competencies.
• Establish regular IFSS partner communication to assess learner needs.
• Establish learning paths for HAF regulatory and laboratory officials for the various program areas within the IFSS.
• Facilitate and share responsibility for training/learning resource content development across SLTT partners, educational institutions, private training providers, and other IFSS partners.

TRAINING DESIGN

• Develop alternative processes, procedures, and opportunities for learners to demonstrate mastery of NCS competencies.
• Design and implement a process for determining alignment of partner credentialing programs with NCS competencies.
• Focus on practical application.
• Design training/learning resources to align to NCS competencies. 
• Ensure 508 compliance for all materials, where applicable.
• Bridge the gaps between scientific knowledge, policy, and real-life field application.
• Include adaptable content for diverse industries and regions.
• Use various delivery methods: virtual, in-person, hybrid, synchronous, and asynchronous.
• Ensure content reflects current principles and regulatory requirements.
• Ensure NCC-approved training/learning resources include an assessment to measure individual mastery of NCS competencies.

TRAINING DELIVERY

• Utilize a national LMS to identify NCC-approved courses/learning resources and their alignment with NCS competencies, maintain competency profiles for all IFSS HAF regulators and laboratorians, and coordinate IFSS registration for training/learning resources.
• Make online training/learning resources accessible and free (or low-cost) when possible.
• Publicize NCC-approved training/learning resource opportunities in the national LMS, and facilitate registrations.
• Offer diverse delivery methods to cater to different learning styles.
• Collaborate with stakeholders to broaden training/learning resource availability.
• Facilitate collaboration for creating training/learning resources in various modalities.
• Universally track and report on individual competency completion and needs.
• The awardee will deploy the LMS within 6 months of being awarded the cooperative agreement.

MANAGEMENT AND MAINTENANCE

• Stand up and manage the RLTS National Coordination Center (NCC) to oversee the day-to-day operation of the RLTS.
• Recommend changes and improvements to the RLTS strategic plan, implementation plan, and RLTS governance structure to best meet the needs of the IFSS RLTS.
• Facilitate collaboration: Facilitate activities required by the NCC, report progress to the RLTS Steering Committee (SC) and adhere to the guidance and direction of the RLTS SC to ensure consistent planning and implementation.
• Standardize training/learning resources: Develop and maintain a standardized curriculum and evaluation system to ensure training/learning resource consistency and effectiveness.
• Review conflict of interest: Establish a process to review and mitigate potential conflicts within NCC operations.
• Leadership sustainability: Build sustainability into the leadership structure, identify qualities for sustainable governance, and create succession plans.
• Efficient management: Establish processes for managing personnel and fiscal resources, ensure SLTT representation, and maximize cost-effectiveness of training/learning resource delivery.
• SLTT Licensing Fees: Utilize up to $250k of grant award to support SLTT free access to the LMS and maintenance of individual competency profiles for all IFSS regulators and laboratorians.
• Employ fee structure, if necessary, to ensure long-term financial sustainment of the NCC and encourage a shared commitment for training among IFSS partners. The fee structure, if utilized, must be approved by the RLTS SC.

COLLABORATION AND CONSISTENCY

• Establish and utilize training/learning resource content, design, and delivery standards to ensure the quality and consistency of training/learning resources that are offered in the RLTS LMS.
• Establish process for IFSS stakeholders to recommend changes to the RLTS quality standards.
• Develop and implement a communications/marketing plan to encourage IFSS stakeholder participation in the RLTS.
• Establish and implement a quality assurance system that includes reviewing IFSS partner courses/learning resources for alignment with RLTS quality standards and mapping the course/learning resource learning objectives to the NCS competencies.
• Establish and implement a quality control system for ensuring adherence to RLTS quality standards and encourage free market competition among training providers.
• Support establishment, operation, and maintenance of a national LMS to house the competency profiles of all FDA/SLTT regulators and laboratorians, link approved training/learning resources to the NCS competencies, host training courses/learning resources, facilitate registration, and track successful completion of training courses/learning resources by learners.
• Collaborate with the FDA on the delivery of train-the-trainer (TTT) courses and maintenance of qualified instructor lists.
• Evaluate training: Establish a robust process to measure quality of training/learning resources through objective evaluation and data collection.
• Track performance measures: Track performance measures specified in the RLTS Implementation Plan to determine the effectiveness of the RLTS. Recommend other metrics, as necessary, to assess the effectiveness of the RLTS, NCC-approved courses/learning resources, delivery methods, etc. Place special emphasis in measuring and reporting on the various public health impacts resulting directly and indirectly from this grant project.
• Long-term improvement: Conduct evaluations to identify gaps and determine the effectiveness of training in practical applications.
• Self-sustainability: By the end of year 1, the grantee will provide FDA with a self-sustainability plan detailing how the NCC and LMS will operate, after awarded and over the following nine-year period, with and without, future federal support.

Letters of Support: Provide any letters of support that are specific to the project. Include letters of commitment to the collaboration and support for project sustainment by private and public sector partners or collaborators.

LMS: The NCC must ensure personally identifiable information (PII) is protected and that data in the LMS remains the property of the NCC if/when changes in the LMS contractor occur.  

The NCC will develop processes and procedures for identifying and mitigating potential and perceived conflicts of interest within the IFSS RLTS operations through systematic and transparent oversight with mechanisms for anonymous submission of concerns. This includes potential and perceived conflicts of interest from the NCC developing and delivering courses/learning resources while also serving as the body that reviews/approves IFSS partner courses/learning resources to ensure alignment with RLTS quality standards.

The NCC will develop and implement a process for IFSS partners to appeal the decisions of the NCC related to the alignment of courses/learning resources to RLTS quality standards and NCS competencies. 

FDA’s Role: FDA provides SMEs for training content regarding FDA regulations, policy, project oversight, scientific input, content review, and programmatic interaction with awardee(s) on activities within the scope of this cooperative agreement program (grant). The FDA and RLTS Steering Committee will have substantial involvement, oversight, and responsibility over the IFSS RLTS and the operations of the NCC.

The NCC will recommend to the RLTS Steering Committee any necessary changes to the RLTS strategic plan, implementation plan, and governance structure to facilitate a more efficient and effective RLTS.

Structure and Function: Utilize, adhere to, and directly reference in the application how your project plan integrates the foundational IFSS RLTS documents (e.g. Strategic Plan, Implementation Plan, and governance structure) located at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/integrated-food-safety-system-ifss-programs-and-initiatives/ifss-regulatory-and-laboratory-training-system-rlts.

Reporting: The grantee will participate in project update meetings with the RLTS Steering Committee monthly with up to 4 face-to-face meetings annually. The grantee will develop a reporting template that covers accomplishments, challenges, risks, and lessons learned (or will utilize an Office of Domestic Partnerships (ODP)-developed reporting template). Reporting metrics will be comprehensive and clearly demonstrate activities being conducted under this funding. Examples of necessary metrics include, but are not limited to, the following:          

# courses/learning resources revised to align with changes in regulations, policies, and emerging issues.

# courses/learning resources reviewed to ensure alignment with RLTS quality standards and NCS competencies

% increase in courses/learning resources aligned with NCS from pre-completed NCS inventory

# of new courses/learning resources created where both policy SMEs and instructional SMEs participated in the creation

Specific details regarding identification of IFSS HAF training needs and communication to public

# of courses/learning resources newly aligned with NCS

# of courses/learning resources developed for specific program areas

# of existing courses/learning resources modified or revised to include regional or local regulations or other enhancements

Measure the time required for the NCC to review courses/learning resources that are submitted by IFSS partners for approval and inclusion in the national LMS

# days per submitted course review-through-approval (monthly, quarterly, yearly, mean, etc.)

# of participants per course/learning resource

# of courses/learning resources offered in more than one modality

# of courses/learning resources per modality (with further breakdown by topic, focus, etc.)

% capacity filled per course/learning resource

# wait-listed course/learning resource registrants for specific program area

# different stakeholder groups represented in the NCC, RLTS SC, and RLTS advisory committees

% of turnover in the NCC and RLTS SC

# FTE hours spent to support grant by activity (e.g. training, committee meetings, design)

# SLTT SMEs participating in training/learning resources to provide additional focus on SLTT concerns, rules, process

# courses/learning resources utilizing RLTS quality standards for  content, design, and delivery

% completion of training/learning resource evaluation process

% pass/fail related to training/learning resource assessments designed to measure individual mastery of NCS competencies

# of appeals to NCC decisions

# of NCC decisions reversed or modified following the appeals process

See Section VIII. Other Information for award authorities and regulations.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Other: Only the current recipient of RFA-FD-20-024 under award U18FD007047 is eligible to apply for this funding opportunity. 

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the HHS Grants Policy Statement for additional information

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide. 
 

2. Cost Sharing

This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement. 

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only one (1) application is allowed from the current recipient of RFA-FD-20-024 under award U18FD007047. 

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

• Project Management plans, milestones, and timelines (to include Gantt charts)
• Business proposals and supporting documents
• Learning Management System general specifications 
• Strategic plans and related documentation
• Legacy documentation from previous related work to be considered in this application. 
   

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or FDA-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. FDA and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the FDA Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement. 

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to the FDA. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and comliance with application instructions by the assigned FDA Grants Management Specialist and responsiveness by components of participating organizations. Applications that are incomplete or noncompliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the FDA in support of the FDA mission are evaluated for scientific and technical merit through the FDA objective review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee convened by the FDA, using the stated review criteria. Assignment to an Objective Review Committee will be shown in eRA Commons.

As part of the objective review, all applications will receive a written critique.

The application will undergo technical evaluation and will be assigned overall impact scores and assessed by subject matter experts for a funding recommendation to the program and funding office.  

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement. 

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the HHS Grants Policy Statement.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. 

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that FDA research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. The FDA will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the FDA as defined below.

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA staff being substantially involved as a partner with the PD/PI, as described below.

The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project. This individual will work closely with designated officials within the recipient organization and with partner organizations to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge federal support in publications, announcements, news programs, and other media; and ensure compliance with other federal, regulatory, and organizational requirements.

FDA/HFP Program Staff will have substantial programmatic involvement that is above and beyond the normal programmatic oversight, monitoring, and stewardship of awards, as described below:

• Collaborate on the development and maintenance of the IFSS Food Protection Professionals National Curriculum Standard (NCS) and Food and Feed Laboratory National Curriculum Standard.
• Collaborate to identify and prioritize the training needs of HAF regulatory and laboratory officials.
• Collaborate to support the delivery of train-the-trainer (TTT) courses and maintenance of qualified instructor lists.
• Provides SMEs for training content regarding FDA regulations, policy, project oversight, scientific input, content review, and programmatic interaction with awardee(s) on activities within the scope of this cooperative agreement program (grant). 
• FDA/HFP will have substantial involvement, oversight, and responsibility over the IFSS RLTS and the operations of the NCC.

3. Data Management and Sharing

Consistent with the FDA Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement. 

Program Income Reporting:

Program Income must be reported on the Federal Financial Report (FFR) SF-425.

Any Program Income generated during the Project Period by the recipient or sub-recipient of an award issued under this NOFO will be treated as identified below.

Treatment of Program Income:
Additional Costs

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. . FDA NOFOs outline intended research goals and objectives. Post award, the FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Graham N. Giesen, Public Health Advisor
Human Foods Program (HFP)
Office of Domestic Partnerships (ODP)
Email: [email protected] 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Danielle Head
Office of Acquisitions and Grants Services
Email: [email protected]  

Section VIII. Other Information

Recently issued policy notices may affect your application submission. A full list of policy notices is provided in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. 

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241), section 573(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 360ccc-2(b)) and under Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.